Change Requests

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TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (Proposed Rule)

Key Information

Abstract

EPA is requiring reporting and recordkeeping requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) under the Toxic Substances Control Act (TSCA) as amended by the Fiscal Year 2020 National Defense Authorization Act (NDAA). As mandated by the amendment, EPA will require certain persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011, to electronically report to EPA certain information. This is a one-time reporting event to provide greater transparency on the uses and risks associated with PFAS and is mandated by the NDAA. The total one-time burden and cost of the action are summarized in Table 1. Table 2 annualizes the burden and cost over a three-year ICR approval period (although the reporting is a one-time activity).

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

15 USC 2607	View Law

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Shake Alert

Key Information

Abstract

Abstract The ShakeAlert system was established in compliance with the following authorities • 42 USC 68 Disaster Relief Act §5132. Disaster warnings • 42 USC 7701 Earthquake Hazards Reduction Act 2004.§7701. The collection of information is necessary as its findings has the potential to save lives Readiness of Federal agencies to issue warnings to State and local officials. The President shall insure that all appropriate Federal agencies are prepared to issue warnings of disasters to State and local officials. As the earthquake detection improves, the messages to populations can save lives by providing seconds of warning that strong shaking from an earthquake is coming. These seconds of extra warning can help people take protective actions, like Drop, Cover, and Hold On (DCHO) to reduce their risk of personal injury. Because seconds matter with ShakeAlert, we need to understand more about how the various parts of the alerting system work and what technical latencies or lag times exist. Without these studies, we would not understand how much time it will take for a Wireless Emergency Alert (WEA) to arrive on the devices of people. This critical information allows to better understand the channels that will be using ShakeAlerts, to determine how long it will take for people to receive the messages, so we can assist in providing information on the best protective actions in their circumstance.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 68	View Law

42 USC 7701	View Law

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NSPS for Grain Elevators (40 CFR part 60, subpart DD) (Renewal)

Key Information

Abstract

The New Source Performance Standards (NSPS) for the regulations published at 40 CFR Part 60, Subpart DD were proposed on January 18, 1977, and promulgated on August 3, 1978. These regulations apply to existing facilities and new facilities located at grain elevators: each truck unloading station, truck loading station, railcar unloading station, railcar loading station, grain dryer, and all grain handling operations commencing construction, modification or reconstruction after August 3, 1978. This information is being collected to assure compliance with 40 CFR Part 60, Subpart DD. In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 7401 et seq.	View Law

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Pesticides Data Call In Program (Renewal)

Key Information

Abstract

This ICR covers the information collection (IC) activities associated with the issuance of data-call-ins (DCIs) under section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA regulates the use of pesticides under the authority of two federal statutes: FIFRA and the Federal Food, Drug and Cosmetic Act (FFDCA) , both as amended by the Food Quality Protection Act (FQPA) of 1996. In general, before manufacturers can sell pesticides in the United States, EPA must evaluate the pesticides thoroughly to ensure that they meet federal safety standards to protect human health and the environment. EPA grants a "registration" or license that permits a pesticide's distribution, sale, and use only after the company meets the scientific and regulatory requirements. FIFRA also requires EPA to assess whether the continued registration of a pesticide causes unreasonable adverse effects on human health or the environment and to decide whether to pursue appropriate regulatory measures. EPA uses the DCIs issued under this ICR to acquire the data necessary to support registration review. In evaluating a pesticide registration application, EPA assesses a wide variety of potential human health and environmental effects associated with the use of the product. Applicants, or potential registrants, must generate or provide the scientific data necessary to address concerns pertaining to the identity, composition, potential adverse effects, and environmental fate of each pesticide. The data allow EPA to evaluate whether a pesticide has the potential to cause harmful effects to human health and the environment, including effects to non-target organisms, federally threatened and endangered (listed) species, and to surface water or ground water. Through a rigorous scientific and public process, EPA specifies the kinds of data and information necessary to make regulatory judgments about the risks and benefits of pesticide products under FIFRA section 3, 4 and 5, as well as the data and information needed to determine the safety of pesticide chemical residues under FFDCA section 408. The regulations in 40 CFR part 158 describe the minimum data and information EPA typically requires to support an application for pesticide registration or amendment; support the reregistration of a pesticide product; support the maintenance of a pesticide registration by means of the data call-in process (e.g., as used in the registration review program); or establish or maintain a tolerance or exemption from the requirements of a tolerance for a pesticide chemical residue. As described in 40 CFR 158.30, however, FIFRA provides EPA with flexibility to require, or not require, data and information for the purposes of making regulatory judgments for individual pesticide products, thereby allowing for the data required to be modified on an individual basis to fully characterize the use and properties, characteristics, or effects of specific pesticide products under review. EPA may, therefore, require the submission of additional data or information beyond that specified in the regulations if such data or information are needed to evaluate a pesticide product as required by FIFRA and FFDCA. This ICR describes how DCIs are issued and presents the Agency’s estimates of the information collection burden and costs associated with issuing DCIs.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

21 USC 346a	View Law

7 USC 136 et seq.	View Law

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NSPS for Flexible Vinyl and Urethane Coating and Printing (40 CFR part 60, subpart FFF) (Renewal)

Key Information

Abstract

The New Source Performance Standards (NSPS) for Flexible Vinyl and Urethane Coating and Printing were promulgated on June 29, 1984; and amended on October 17, 2000. These regulations apply to facilities with rotogravure printing lines used to either print or coat flexible vinyl or urethane products for which construction, modification or reconstruction commenced after January 18, 1983. This information is being collected to assure compliance with 40 CFR Part 60, Subpart FFF. In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to the NSPS.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 7401 et seq.	View Law

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10 CFR 4, Nondiscrimination in Federally Assisted Commission Programs

Key Information

Abstract

All recipients of Federal financial assistance from the NRC are subject to the provisions of 10 CFR Part 4, “Nondiscrimination in Federally Assisted Programs or Activities Receiving Assistance from the Commission.” Respondents must notify participants, beneficiaries, applicants, and employees of nondiscrimination practices and keep records of Federal financial assistance and of their own self-evaluations of policies and practices. NRC Form 781, “SBCR Compliance Review” is a required form that should be submitted by the recipient upon initiation or modification of a program, during the pre-award and post-award stage, periodic monitoring, and, if a complaint is being processed during the pre-award application phase and upon request from an authorized NRC official during the post-award review phase. This information is necessary for determining whether any persons are or will be denied such services provided by the primary funding recipient on the basis of prohibited discrimination. In the event that discrimination is alleged in NRC- conducted and Federal financially assisted programs and activities, it may be reported using NRC Form 782.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 83 - 703 1-311	View Law

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NSPS for Kraft Pulp Mills (40 CFR Part 60, Subpart BB) (Renewal)

Key Information

Abstract

The New Source Performance Standards (NSPS) for the regulations published at 40 CFR Part 60, Subpart BB were proposed on September 24, 1976, promulgated on February 23, 1978, and amended on April 4, 2014. These regulations apply to the following facilities at existing kraft pulp mills that commenced construction, reconstruction, or modification after September 24, 1976 and on or before May 23, 2013: recovery furnaces, smelt dissolving tanks, lime kilns, digester systems, brown stock washer systems, black liquor oxidation systems, multiple effect evaporator systems and condensate stripper systems. In pulp mills where kraft pulping is combined with neutral sulfite semi-chemical pulping, the provisions of this Subpart are applicable when any portion of the material charged to an affected facility is produced by the kraft pulping operation. This information is being collected to assure compliance with 40 CFR Part 60, Subpart BB. New facilities that commenced construction, modification or reconstruction after May 23, 2013 are subject to regulation under 40 CFR Part 60 Subpart BBa. In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 7401 et seq	View Law

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Advances to Housing Associates

Key Information

Abstract

Enables the Federal Home Loan Banks and, where appropriate, the Federal Housing Finance Agency to determine if a respondent satisfies the statutory and regulatory requirements to be certified initially, and to maintain its status as a housing associate eligible to receive Bank advances.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

12 USC 1430b	View Law

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Certification and Compliance Requirements for Nonroad Spark-ignition Engines (Renewal)

Key Information

Abstract

This information collection is requested under the authority of Title II of the Clean Air Act (42 U.S.C. 7521 et seq.) Under this Title, EPA is charged with issuing certificates of conformity for those engines which comply with applicable emission standards. Such a certificate must be issued before engines may be legally introduced into commerce. To apply for a certificate of conformity, manufacturers are required to submit descriptions of their planned production line, including detailed descriptions of the emission control system, and test data. This information is organized by engine family groups expected to have similar emission characteristics. The emission values achieved during certification testing may also be used in the Averaging, Banking, and Trading (ABT) Program. The program allows manufacturers to bank credits for engine families that emit below the standard and use the credits for families that emit above the standard. They may also trade banked credits with other manufacturers. Participation in the ABT program is voluntary. Different categories of spark-ignition engines may also be required to comply with production-line testing (PLT) and in-use testing. There are also recordkeeping and labeling requirements. This information is collected electronically by the Gasoline Engine Compliance Branch (GECB), Implementation, Analysis and Compliance Division, Office of Transportation and Air Quality (OTAQ), Office of Air and Radiation of the U.S. Environmental Protection Agency. GECC uses this information to ensure that manufacturers comply with applicable regulations and the Clean Air Act (CAA). It may also be used by the Office of Enforcement and Compliance Assurance (OECA) and the Department of Justice for enforcement purposes. Non-CBI may be disclosed on OTAQ's Web site or upon request under the Freedom of Information Act (FOIA) to trade associations, environmental groups, and the public. Any information submitted for which a claim of confidentiality is made is safeguarded according to EPA regulations at 40 CFR 2.201 et seq.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 7521	View Law

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NESHAP for Stationary Reciprocating Internal Combustion Engines (40 CFR part 63, subpart ZZZZ) (Final Rule)

Key Information

Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP) for Stationary Reciprocating Internal Combustion Engines (40 CFR Part 63, Subpart ZZZZ) were proposed on December 19, 2002: promulgated on June 15, 2004; and revised on: June 26, 2006; January 18, 2008; January 30, 2013; and February 27, 2014, and August 10, 2022. These regulations apply to owners and operators of a stationary reciprocating internal combustion engines (RICE) at either a major or area source of hazardous air pollutant (HAP) emissions, except if the stationary RICE is being tested at a stationary RICE test cell/stand. A stationary RICE is any internal combustion engine which uses reciprocating motion to convert heat energy into mechanical work and which is not mobile. New facilities include those that commenced construction, modification or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR Part 63, Subpart ZZZZ. In general, all NESHAP standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NESHAP. Current amendments to the regulations mainly add electronic reporting provisions to the rule. In general, the changes do not result in regulated entities needing to submit anything additional electronically that is not currently submitted via paper copies, and this is therefore expected to lessen recordkeeping and reporting burden. This supporting statement addresses incremental information collection activities that will be imposed by the amendments to the NESHAP for Stationary Reciprocating Internal Combustion Engines.

Federal Register Notices

60-Day FRN	View Notice

Authorizing Statutes

42 USC Sec. 7401 et seq.	View Law

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TSCA Section 5 Premanufacture Review of New Chemical Substances and Significant New Use Rules for New and Existing Chemical Substances (Renewal)

Key Information

Abstract

This information collection request addresses the reporting and recordkeeping requirements associated with both the new chemicals review and regulatory program and the existing chemicals program administered by EPA under section 5 of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Lautenberg Act) (15 U.S.C. 2604). EPA is requesting to renew and consolidating two existing approved Information Collection Requests (ICRs). This consolidated ICR will cover information collection activities associated with Significant New Use Rules (SNURs) for both new and existing chemicals under TSCA. The information for SNURs and required notifications includes chemical identity, use and exposure information, test information and descriptions of other information related to the effects on health and the environment of the manufacture, processing, use, distribution in commerce and disposal of the new or existing chemical substance. This ICR is required for the information to be collected under notices for Significant New Use Rules for new and existing chemicals.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

15 USC 2604	View Law

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Application for Survivor Death Benefits

Key Information

Abstract

The collection obtains the information needed to pay death benefits and annuities due but unpaid at death under the Railroad Retirement Act. Benefits are paid to designated beneficiaries or to survivors in a priority designated by law.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

45 USC 231(f) et seq	View Law

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Hazardous Materials Program Requirements (Previously Hazardous Materials Training Requirements)

Key Information

Abstract

As prescribed in Title 14 of the Code of Federal Regulations (14 CFR) parts 121 and 135, the FAA requires certificate holders to submit hazardous materials (hazmat) procedures and information (sometimes referred to as hazmat manuals) and hazmat training programs as a part of the FAA’s certification process. In addition, revisions to an approved hazmat training program must be submitted following certification to obtain initial and final approval as part of the FAA’s certification process. Revisions to an accepted manual may be requested following certification. Initial certification is completed in accordance with 14 CFR part 119. Continuing certification is completed in accordance with 14 CFR parts 121 and 135. The FAA uses the certification process to review the certificate holder’s hazmat manual and training programs for compliance with the applicable regulations, national policies, and safe operating practices. It also ensures that the documents adequately establish safe operating procedures. Additionally, 14 CFR part 145 requires certain repair stations to provide documentation showing that persons handling hazmat for transportation have been trained in accordance with 49 CFR parts 171 through 180. The submission of this documentation is covered in this information collection.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

49 USC 44702	View Law

49 USC 44701	View Law

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License Exemptions and Other Authorizations

Key Information

Abstract

Over the years, BIS has worked with other Government agencies and the affected public to identify areas where export licensing requirements may be relaxed without jeopardizing U.S. national security or foreign policy. Many of these relaxations have taken the form of licensing exceptions, as well as other types of authorizations or exclusions. Some of these license exceptions, other authorizations, and exclusions have a reporting or recordkeeping requirement to enable the Government to continue to monitor exports of these items. Exporters may choose to utilize the license exception and accept the reporting or recordkeeping burden in lieu of submitting a license application.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 115 - 232 B	View Law

50 USC 1702	View Law

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Part 1239 Clauses 1252.239-72 and 1252-239-74

Key Information

Abstract

The Department of Transportation is requesting an extension without change of a previously approved information collection. Under Public Law 113-283, section 2521 Federal Information Security Modernization Act of 2014, each agency of the Federal Government must provide security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. This is a mandatory requirement. Small businesses will be affected in the same way as large businesses to comply with statutes and other Federal requirements which require security of information technology, information and information systems.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 113 - 283 1	View Law

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Part 1239 Clause 1252.239-70

Key Information

Abstract

The Department of Transportation is requesting an extension without change of a previously approved information collection. Under Public Law 113-283, section 2521 Federal Information Security Modernization Act of 2014, each agency of the Federal Government must provide security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. This is a mandatory requirement. Small businesses will be affected in the same way as large businesses to comply with statutes and other Federal requirements which require security of information technology, information and information systems. DOT provided a 60-day comment period for the public to respond to the proposed rule and submit comments. The public comment period closed on February 7, 2022. DOT received no public comments on the proposed rule and no public comments were received on any of the information collection requirements in the rule. The final rule is estimated to be published in the month of September 2022.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 113 - 283 1	View Law

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Part 1239 Clauses 1252.239-89 and 1252-239-90

Key Information

Abstract

The Department of Transportation is requesting an extension without change of a previously approved information collection. Under Public Law 113-283, section 2521 Federal Information Security Modernization Act of 2014, each agency of the Federal Government must provide security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. This is a mandatory requirement. Small businesses will be affected in the same way as large businesses to comply with statutes and other Federal requirements which require security of information technology, information and information systems.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 113 - 283 1	View Law

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Part 1239 Clause 1252.239-75

Key Information

Abstract

The Department of Transportation is requesting an extension without change of a previously approved information collection. Under Public Law 113-283, section 2521 Federal Information Security Modernization Act of 2014, each agency of the Federal Government must provide security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. This is a mandatory requirement. Small businesses will be affected in the same way as large businesses to comply with statutes and other Federal requirements which require security of information technology, information and information systems.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 113 - 283 1	View Law

Presidential Action:

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Part 1239 Clauses 1252.239-76; 1252-239-77; 1252-239-80; 1252-239-83; 1252-239-85; and 1252-239-88.

Key Information

Abstract

The Department of Transportation is requesting an extension without change of a previously approved information collection. Under Public Law 113-283, section 2521 Federal Information Security Modernization Act of 2014, each agency of the Federal Government must provide security for the information and information systems that support the operations and assets of the agency, including those provided or managed by another agency, contractor, or other source. This is a mandatory requirement. Small businesses will be affected in the same way as large businesses to comply with statutes and other Federal requirements which require security of information technology, information and information systems.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 113 - 283 1	View Law

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[Medicaid] Medical Necessity and Contract Amendments Under Mental Health Parity (CMS-10556)

Key Information

Abstract

The final rule amends the Medicaid and CHIP regulations to implement the Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). MHPAEA is a federal law that generally prevents group health plans and health insurance issuers that provide mental health or substance use disorder (MH/SUD) benefits from imposing less favorable benefit limitations on those benefits than on medical/surgical benefits. The final rule applies mental health parity requirements to Medicaid Managed Care Organizations (MCOs), Section 1937 Alternative Benefit Plans (ABPs), and the CHIP. The final rule also contains provisions related to the disclosure of information related to the reason for denial of reimbursement or payment for MH/SUD benefits. The text only clarifies the expectations for disclosing information concerning the denial of reimbursement or payment for MH/SUD benefits. It does not impose any new or revised third-party disclosure requirements.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 111 - 3 502	View Law

Pub.L. 110 - 343 512(b)	View Law

Pub.L. 111 - 148 2001(c)	View Law

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Medicare Coverage of Items and Services in FDA Investigational Device Exemption Clinical Studies--Revision of Medicare Coverage (CMS-10511)

Key Information

Abstract

Section 1862(m) of the Act (established by section 731(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 8, 2003)) allows for payment of the routine costs of care furnished to Medicare beneficiaries in a Category A investigational device exemption (IDE) trial and authorizes the Secretary to establish criteria to ensure that Category A IDE trials conform to appropriate scientific and ethical standards. By providing Medicare coverage of routine costs in Category A trials, the Congress removed a financial barrier that may have discouraged beneficiaries from participating in these trials. It also gives Medicare beneficiaries the opportunity to have earlier access to new medical devices. Based on our rulemaking authority in section 1871 of the Act, we are applying the same Medicare coverage requirements and scientific and ethical standards to Medicare coverage related to Category B IDE studies/trials that would be applicable to Category A IDE studies/trials. CMS (or its designated entity) must review the following to determine if the Medicare coverage IDE study criteria in ?405.212 are met for purposes of coverage of items and services described in paragraphs (a) and (b) of this section: (1) FDA IDE approval letter. (2) IDE study protocol. (3) IRB approval letter. (4) National Clinical Trials (NCT) number. (5) Supporting materials, as needed.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 1102	View Law

42 USC 1861	View Law

42 USC 205(a)	View Law

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Payment of Indemnity and Compensation for Highly Pathogenic Avian Influenza

Key Information

Abstract

Interim final rule amending regulations related to conditions for payment of indemnity and compensation for highly pathogenic avian influenza claims. Amendments include new activities related to biosecurity audits and instrument for conducting same, and reconsideration process for audit results.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

Pub.L. 107 - 171 10401-18	View Law

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Maritime Administration (MARAD) Mariner Preparedness Exercise (PrepEx) Survey (MARAD Mariner PrepEx Survey)

Key Information

Abstract

This is a survey that will be conducted on a voluntary basis that provides vital information to the Ready Reserve Force Program. This exercise is designed to test MARAD’s internal administrative procedures, as well as the coordination necessary for a complete activation of MARAD's Ready Reserve Force (RRF) and the Military Sealift Command (MSC) Surge Sealift Fleet to meet strategic sealift requirements. Periodic testing is necessary in view of the dynamics that affect the RRF program, which include changes in RRF fleet composition, readiness status, ship location as well as changes to the seafaring manpower base.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

49 USC 192	View Law

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National Geological and Geophysical Data Preservation Program (NGGDPP)

Key Information

Abstract

The USGS NGGDPP offers financial support to State geological agencies to create metadata that will describe sample sites for State geological surveys that have related site-specific data resources. The purpose of these data collections are to preserve and provide access to samples (and any related data) that have been extracted from the earth to improve the breadth of information that can be used to inform science and decision-making now and in the future. The USGS envisions a national network of cooperating geoscience materials and data repositories that are operated independently yet guided by common standards, procedures, and protocols for metadata. The holdings of all collections will be widely accessible through a common and mirrored Internet-based catalog, the National Digital Catalog. The holdings of the individual repositories will complement each other to preserve the geoscience assets of the Nation and serve as a comprehensive source of geoscience data and materials to serve national needs today and in the future.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

42 USC 15801	View Law

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Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs

Key Information

Abstract

This information collection supports information collection requirements under the Current Good Manufacturing Practice regulations for Positron Emission Tomography (PET) drugs. The regulations establish recordkeeping requirements that include: Batch Production and Control Records; Equipment and Facilities Records; Records of Components, Containers, and Closures; Process Vertification; Laboratory Testing Records; Sterility Test Failure Notices; Conditional Final Releases; Out-of-Specification Investigations; Reprocessing Procedures; Distribution Records; and Complaints. The regulations also require 3rd Party Disclosure requirements regarding specific notices. Respondents to the collection are manufacturers of PET drugs.

Federal Register Notices

60-Day FRN	View Notice
30-Day FRN	View Notice

Authorizing Statutes

21 USC 301 et. seq.	View Law

Presidential Action: